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Table 2 National Cancer Institute Common Toxicity Criteria for Adverse Events in study population (n = 15)

From: Phase I clinical trial of a novel autologous modified-DC vaccine in patients with resected NSCLC

A
Adverse Event Total, n (%)
N = 15
  Any Grade Grade 1–2 Grade 3–4
Pyrexia 6 (40%) 6 (40%) 0
Fatigue 5 (33.33%) 5 (33.33%) 0
Palpitate 1 (6.67%) 1 (6.67%) 0
Headache 3 (20%) 3 (20%) 0
Chest pain 1 (6.67%) 1 (6.67%) 0
Chest Congestion 1 (6.67%) 1 (6.67%) 0
Abdominal pain 5 (33.33%) 5 (33.33%) 0
Abdominal distension 2 (13.33%) 2 (13.33%) 0
Nausea 3 (20%) 3 (20%) 0
Hypertension 1 (6.67%) 1 (6.67%) 0
Nasal congestion 1 (6.67%) 1 (6.67%) 0
CRP increased 7 (46.67%) 7 (46.67%) 0
Myalgia 6 (40%) 6 (40%) 0
Creatinine increased 2 (13.33%) 2 (13.33%) 0
Chills 1 (6.67%) 1 (6.67%) 0
B
Adverse Event 1 × 106, n (%) 1 × 107, n (%) Maximum numbersof cultured cell, n (%)
  N = 3 N = 3 N = 9
  Any Grade Grade 1–2 Grade 3–4 Any Grade Grade 1–2 Grade 3–4 Any Grade Grade 1–2 Grade 3–4
Pyrexia 0 0 0 1 (33.33%) 1 (33.33%) 0 5 (55.56%) 5 (55.56%) 0
Fatigue 1 (33.33%) 1 (33.33%) 0 1 (33.33%) 1 (33.33%) 0 3 (33.33%) 3 (33.33%) 0
Palpitate 1 (33.33%) 1 (33.33%) 0 0 0 0 0 0 0
Headache 1 (33.33%) 1 (33.33%) 0 1 (33.33%) 1 (33.33%) 0 1 (11.11%) 1 (11.11%) 0
Chest pain 1 (33.33%) 1 (33.33%) 0 0 0 0 0 0 0
Chest Congestion 1 (33.33%) 1 (33.33%) 0 0 0 0 0 0 0
Abdominal pain 3 (100%) 3 (100%) 0 0 0 0 2 (22.22%) 2 (22.22%) 0
Abdominal distension 0 0 0 1 (33.33%) 1 (33.33%) 0 1 (11.11%) 1 (11.11%) 0
Nausea 1 (33.33%) 1(33.33%) 0 0 0 0 2 (22.22%) 2 (22.22%) 0
Hypertension 0 0 0 1(33.33%) 1(33.33%) 0 0 0 0
Nasal congestion 1 (33.33%) 1 (33.33%) 0 0 0 0 0 0 0
CRP increased 2 (66.67%) 2 (66.67%) 0 1 (33.33%) 1 (33.33%) 0 4 (44.44%) 4 (44.44%) 0
Myalgia 1 (33.33%) 1 (33.33%) 0 1 (33.33%) 1 (33.33%) 0 4 (44.44%) 4 (44.44%) 0
Creatinine increased 0 0 0 2 (66.67%) 2 (66.67%) 0 0 0 0
Chills 1 (33.33%) 1 (33.33%) 0 0 0 0 0 0 0